Current and anticipated regulatory frameworks, built around often inappropriate western, evidence-based, scientific methods of evaluation of both efficacy and risks of natural therapies, present a very serious threat to the continuation and expansion of these therapies. Some of the greatest threats originate from the complex European regulatory model, that also forms the basis for international guidelines and standards in the process of being developed through the UN organ, the Codex Alimentarius Commission.
Click on the links below to read about how this EU legislation may affect you:
Food Supplements Directive
ANH briefing paper FSD / General
ANH briefing paper FSD / MPLs
ANH position paper on MPLs (Oct 2007): "MPLs Not Fit for Purpose"
ANH article (Jan 2008) "Why should we be concerned about MPLs?"
EC Draft Commission Regulation Annex I and II
During June 2009 the European Food Safety Authority (EFSA) completed its assessment of all the dossiers submitted during the derogation period of the transition measures under Article 4(6) of the EU Food Supplements Directive (2002/46/EC). The updated version of the draft European Commission Regulation intended to amend the Food Supplements Directive to add the substances which received a favourable opinion from EFSA to those already listed on the Positive List in Annex II of the Directive. The draft Regulation reflected all the substances for which EFSA gave positive opinions and has took the Positive List to 181 allowed forms of vitamins and minerals.
This draft Regulation then went forward for consideration by a Scrutiny Committee and then to the European Parliament and Council. When the Regulation was enacted amendments took place within the statutory instrument for each Member State in order for its implementation into law. The end of the derogation period was officially 31st December 2009 and products containing forms of vitamins and minerals that were not listed on the amended Annex II became illegal under EU law and prohibited from sale.
Practitioners should be aware that there are some substantial gaps and that some forms of vitamins and minerals commonly used in food supplements were no longer allowed from the beginning of 2010. For example many of the amino acid chelates and vanadium received negative opinions and are not on Annex II. We would be grateful if you could take the time to check products that you currently use and let us know of any specific forms of vitamins and minerals that are not listed so that we might include this in our submission of stakeholder comments.
Traditional Herbal Medicinal Products Directive
Important! If you use herbs in your practice, please visit our EU herb challenge webpage
European Commission summary
EC specific provisions
ANH briefing paper THMPD
ANH response to EMEA re THMPD challenges
EC Medicinal products for human use (herbal) - Major developments
Foodstuffs Intended for Particular Nutritional Uses (Parnuts) Directive
Medical Devices Directive
European Commission summary
This section under construction
Negative publicity that may affect your business includes headlines such as:
Daily Mail 16/04/08: ''Can vitamins do you harm?'' Supplements may even shorten your life, claim scientists’’. This came from a review published by Cochrane Collaboration.
Click here to read ANH’s rebuttal.
More of this section under construction
US and International Associations
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